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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-27
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/11/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) fever and infection documented in describe event or problem are being reported under mfr # 3004753838-2016-80564.
 
Event Description
Dexcom was made aware on 09/15/2016, that on (b)(6) 2016, the patient experienced a detached sensor wire. The sensor was inserted into the abdomen on (b)(6) 2016. The sensor failed to initiate as expected within period beyond 2 hours and sensor pod was removed. Upon removal, the patient's mother observed no sensor wire on the skin side of the sensor pod. The patient's mother brought the patient into the medical center's pediatric endocrinology due to discomfort during use of the continuous glucose monitoring (cgm) system. The patient had an x-ray during the same doctor's visit and the doctor found the sensor wire was detached at 1/4 f an inch within the patient's skin. The doctor requested for immediate, surgical removal. At the time of contact, the patient was stable but had a fever from an infection and was taking antibiotics. No product or data was returned for investigation. However, a copy of the pathology report was provided for evaluation. The reported event of detached sensor wire was confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key6027109
MDR Text Key57346039
Report Number3004753838-2016-80565
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)NI(17)NI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/13/2016 Patient Sequence Number: 1
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